Description

Nilutamide EP Impurity D is a specified impurity and reference standard used in the quality control of the active pharmaceutical ingredient Nilutamide. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by providing a benchmark for analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and production of anti-androgen medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Nilutamide EP Impurity D in Nilutamide API and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine quality control testing to ensure API batches comply with pharmacopeial specifications (e.g., EP, USP).
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides necessary impurity data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate product quality and control strategy.
• Research & Development: Used in R&D to study the degradation pathways and impurity profile of Nilutamide.

Basic Information

Product Name	Nilutamide EP Impurity D
CAS No.	6167-23-3
Molecular Formula	C12H10F3N3O4
Molecular Weight	317.22 g/mol
Synonyms	5,5-Dimethyl-3-[4-nitro-3-(trifluoromethyl)phenyl]-2,4-imidazolidinedione; Nilutamide Impurity D; Nilutamide Related Compound D; 3-[4-Nitro-3-(trifluoromethyl)phenyl]-5,5-dimethylhydantoin; 5,5-Dimethyl-3-[4-nitro-3-(trifluoromethyl)phenyl]imidazolidine-2,4-dione; Anandron Impurity D; RU 23908 Impurity D
EINECS	Contact for details

Quality Control

Our Nilutamide EP Impurity D is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.